FDA Adverse Event
Malfunction
Summary report: N
PROTEUS
MDR report key: 310658
·
Received December 27, 2000
Report
- Report Number
- 9615534-2000-00002
- Event Type
- Malfunction
- Date Received
- December 27, 2000
- Date of Event
- December 1, 2000
- Manufacturer
- GE HUALUN MEDICAL SYSTEMS
- Product Code
- IZO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEUS | DIAGNOSTIC X-RAY | IZO | GE HUALUN MEDICAL SYSTEMS | 610-3150 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |